User ManualNon-Contact Infrared Body Thermometer

Model MS-131002

Please read this manual before operating this device.It contains important safety information.

HTD8813C

Table of Contents

Foreword...........................................................................................................................................................3Safety Information.......................................................................................................................................3

Warnings............................................................................................................................................................3

1 - Overview.....................................................................................................................................................42 - Operation...................................................................................................................................................73 - Troubleshooting.....................................................................................................................................124 – Replacing the Batteries.....................................................................................................................12

5 – Cleaning, Care and Storage..........................................................................................................13

6 – Disposal......................................................................................................................................................137 – Calibration................................................................................................................................................138– EMC Declaration.....................................................................................................................................14

01

ForewordThis user manual is intended to provide the necessary information for the proper operation of the model MS-131002 non-contact infrared body thermometer.A general knowledge of infrared thermometers and an understanding of the features and functions of the thermometer are prerequisites for proper use.The non-contact infrared body thermometer is a medical device designed to last for three years.Please read this manual before using the thermometer. If you do not fully understand how to use the thermometer, please consult this manual.

Do not operate the thermometer without completely reading and understandingthese instructions.

Warnings

Warnings are identified by the Warning symbol show above.• The non-contact infrared body thermometer is to be operated by consumers in the home setting and primary care setting as a screening tool. The manual, includes directions for use, all precautionary information and specifications should be read before use.• This thermometer is designed to measure human body temperature on the forehead. Do not use it for any other purpose. • This thermometer is intended to be used as a screening tool in a home setting and a primary care setting.• Do not use the thermometer if it malfunctions or has been damaged.• If the ambient temperature changes too much, such as moving the thermometer from a cold room to a warm room, allow the thermometer to adjust to the new temperature. This may take up to 30 minutes. The operating temperature of the thermometer is 59 °F to 95 °F (15 °C to 35 °C).• Remove the batteries if the thermometer is not likely to be used for a long time.• The thermometer is not waterproof. Do not immerse it in water or other liquids. For cleaning and disinfection, please follow the instructions contained in the “Cleaning, Care and Storage” section. • Do not touch the infrared sensor with your fingers.

02

Safety Information

NoticePurchase or possession of this device does not carry any express or implied license to usewith replacement parts which would, alone or in combination with this device, fall within thescope of one of the relating patents.

This device should only be used for the purposes described in these instructions. The manufacturercannot be held liable for the damage caused by incorrect application.The non-contact thermometer is designed to minimize the possibility of hazards from errors in thesoftware program by following human factors design, risk analysis, and software validation processes.

• If a cold compress has been applied to the patient’s forehead, or other physical measures have been used to cool down the patient, avoid using the thermometer, as it may produce a low reading.• When measuring body temperature using the forehead, select “body” mode. When measuring other objects, liquids or foods, select “surface” mode.• This product must be operated in a stable environment. If the ambient environment has changed, water may condense on the surface of the infrared sensor. In the event of condensation on the infrared sensor, see the “Cleaning, Care, and Storage” section for guidance.• Do not use the thermometer near strong electrostatic or magnetic fields. These fields may a�ect the accuracy of the thermometer.• When replacing the batteries, do not mix old and new batteries. This may damage the thermometer.• The accuracy of the measurement may be a�ected if the forehead is covered by hair, perspiration or clothing.• This thermometer is intended for screening. If you have any doubt about the result, please measure the temperature using another method.• The thermometer is calibrated during manufacturing. If used according to the instructions, periodic calibration is not required.

The thermometer should be kept of the reach of children and pets. When not in use, store the device in a dry place and protect it against moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the thermometer or thermometer packaging. Do not dispose of batteries in a fire. Only use recommended batteries. Do not use rechargeable batteries. This thermometer is not designed to replace diagnostic thermometers in hospitals. Do not drop, disassemble or modify the thermometer. Do not use the thermometer if you think it is damaged or notice unusual operation. The thermometer is comprised of sensitive components and must be treated with caution. Observe the storage and operating conditions described in the “Technical Specifications” section. Do not perform service or maintenance while the thermometer is on. When using the thermometer, do not touch the battery and patient simultaneously. Do not use the device if it is damaged/ degraded/ or if any of the thermometer has become loose. The use of a damaged unit may cause improper results or injury. Health Canada Warning: The thermometer is not intended for use on children under the age of two. Based on current science and technology, the thermometer is not known to cause any allergic reactions. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS.

03

04

1 - Overview

Intended UseThe non-contact infrared body thermometer is designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as a screening tool.

Description of Non-Contact Infrared Body Thermometer

Introduction and Operating PrincipleThis non-contact thermometer is a hand-held, reusable, battery-operated device which measures human body temperature via the patient’s forehead.

The operating principle is based on infrared sensor technology. The infrared sensor can output di�erent signals when measuring di�erent object temperatures or in di�erent ambient temperatures.An application-specific integrated circuit then turns the signal from the infrared sensor into a digitalvalue for display on the LCD screen.

Description of Controls, Indicators and Symbols

1. Liquid Crystal Display (LCD)2. Battery Cover3. On/Scan Button4. Set Button5. Memo Button6. Mode Button7. Infrared Sensor

1. Surface Mode2. Body Mode3. Digital Display4. Fever Indicator5. Battery Indicator6. Buzzer On/O�7. Memory Index8. Fahrenheit9. Celsius10. Memory Mode

Figure 1: Overview

Figure 2: Display

HTD8813C/MS-131002 Non-Contact Infrared Body Thermometer

Thermometer Applications

Equipment Symbols

Technical Specifications

Specification Value(s)Measurement Units Fahrenheit (°F) / Celsius (°C)Operating Mode Adjusted mode (Body mode)Direct mode (Surface mode)Measuring Site ForeheadReference Body Site AxillaryRated Output Range Body mode: 95.0 °F – 107.6 °F (35.0 °C – 42.0 °C) Surface mode: 32.0 °F – 212.0 °F (0.0 °C – 100.0 °C)Extended Output Range Body mode: Lower: 93.2 °F – 94.8 °F (34.0 °C – 34.9 °C) Upper: 107.8 °f – 109.2 °F (42.1 C 42.9 °C)

05

ThermometerModel Number Thermometer

Adult Pediatric

Ear Forehead Ear Forehead

59º F

0%

85%

95º F

Warning

Non-Sterile Package

Refer to Operating Instructions

Operating Temperature

Operating Humidity

Manufacturer

Compliance with WEEE Standard

DO NOT THROW AWAY Intended formultiple uses

Operating atmospheric pressure

Serial number

Recyclable

This device complies with Part 15 of FCC (Federal Communications Commission) rules.

Ingress Protection: The first 2 indicates protection from the ingress of solid foreign objects 12.5 mm in diameter and greater. The second 2 indicates protection from the ingress of vertically falling water drops when the enclosure is tilted not greater than 15 degrees from vertical.

ComplianceBasic Safety and Essential EN 60601-1: 2006+A1:2013, EN 60601-1-2:2007PerformanceType of Protection Internally Powered Equipment (on battery power)Degree of Protection Non-Applied Part

Range Body mode: 93.2 °F - 109.2 °F (34.0 °C - 42.9 °C) Surface mode: 32.0 °F – 212.0 °F (0.0 °C – 100.0 °C)Accuracy Body mode: 93.2 °F - 94.8 °F ±0.5 °F (34.0 °C - 34.9 °C ±0.3 °C) 95.0 °F – 107.6 °F ±0.4 °F (35.0 °C – 42.0 °C ±0.2 °C) 107.8 °F – 109.2 °F ±0.5 °F (42.1 °C – 42.9 °C ±0.3 °C) Surface mode: ±3.6 °F (±2.0 °C)Temperature Fahrenheit: 0.1Resolution Celsius: 0.1Three Color Backlight Green - Normal Temperature: 95.9°F – 99.2 °F (35.5 °C – 37.3 °C) Yellow - Slight Fever: 99.3 °F – 100.4 °F (37.4 °C – 38.0 °C) Red - High Fever: 100.5 °F – 109.2 °F (38.1 °C – 42.9 °C)

Notes: 1.Surface Mode always displays a green backlight. 2. In Body Mode, a reading of 93.2 °F – 95.8 °F (34.0 °C – 35.4 °C) displays a green backlight.Auto Power O� ≤ 18 sMeasuring Time ≤ 2 sMeasuring Distance 0.4 – 2.0 in (1 – 5 cm)Memory 50 measurements

06

Power Supply RequirementsBatteries 1.5V AAA Alkaline Battery x 2 (IEC Type LR03)Adaptable Range 2.6V – 3.6V

Environmental ConditionsOperating Conditions Temperature: 59.0 °F – 95.0 °F (15.0 °C – 35.0 °C) Relative Humidity: ≤ 85% Atmospheric Pressure: 70 – 106 KPaTransport and Storage Temperature: -4.0 °F – 131.0 °F (-20.0 °C – 55.0 °C) Relative Humidity: ≤ 93% Atmospheric Pressure: 70 – 106 KPaConditions

Weight(without batteries)

3.0 ounces (84 grams)

Size Length: 5.4” (138mm) Width: 3.7” (95mm) Height: 1.6” (40mm)

Physical Properties

(Color Alarm)

Indicator Calculated ValueClinical Bias (∆cb) -0.027 °CStandard Deviation (σj) 0.14 °CLimits of Agreement (LA) 0.26 °CClinical Repeatability (σr) 0.07 °C

07

2 - Operation

2.1 Battery Installation1) Pull the battery cover forward as indicated by the arrow.2) Insert two AAA-size batteries. Ensure correct polarity as indicated inside the battery cover.3) Slide the battery cover back in until it snaps in place.

2.2 Before Using the ThermometerBe sure to read and understand all warnings listed in the instructions before use.• If the ambient temperature changes too much, such as moving the thermometer from a cold room to a warm room, allow the thermometer to adjust to the new temperature. This may take up to 30 minutes.• The ambient temperature around the patient should be stable. Keep away from large air flows such as fans or air-conditioning vents.• Do not use the thermometer in bright sunlight.• If a patient moves from a colder environment into a warmer test environment, they should remain in the test environment for at least 5 minutes prior to taking a measurement. This will ensure the patient is consistent with the ambient temperature.

Front Panel and Case Labeling EN/ISO 15223-1:2012Temperature EN/ISO 80601-2-56:2012Home Healthcare Environment EN 60601-1-11:2010

Calculated Values of the Indicators According to EN/ISO 80601-2-56

Safety Classification of ME Equipment

Protection against electric shock Internally Powered ME EquipmentApplied Part No Applied PartsProtection against harmful ingress of IP22water or particulate matterMode of Operation Continuous Operation

Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.

The thermometer should be kept of the reach of children and pets. When not in use, store the device in a dry place and protect it against moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the thermometer or thermometer packaging. Do not dispose of batteries in a fire. Only use recommended batteries. Do not use rechargeable batteries. This thermometer is not designed to replace diagnostic thermometers in hospitals. Do not drop, disassemble or modify the thermometer. Do not use the thermometer if you think it is damaged or notice unusual operation. The thermometer is comprised of sensitive components and must be treated with caution. Observe the storage and operating conditions described in the “Technical Specifications” section. Do not perform service or maintenance while the thermometer is on. When using the thermometer, do not touch the battery and patient simultaneously. Do not use the device if it is damaged/ degraded/ or if any of the thermometer has become loose. The use of a damaged unit may cause improper results or injury. Health Canada Warning: The thermometer is not intended for use on children under the age of two. Based on current science and technology, the thermometer is not known to cause any allergic reactions. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS.

08

2.3 Thermometer Self-Test When the thermometer is o�, press the On/Scan button to initiate a self-test. The thermometer will briefly illuminate all segments of the display with green backlighting and then complete a measurement.

2.4 Temperature ModesThe thermometer is capable of measuring body temperature and surface temperature. By default, the thermometer will enter Body Mode when turned on. To toggle between body temperature and surface temperature, press the Mode Button when the device is on.

2.5 Body Temperature Taking a Body Measurement• Align the thermometer with the middle of the forehead to measure body temperature (between and above the eyebrows).• Ensure the distance between the thermometer and the patient’s forehead is between 0.4” and 2.0” (1cm – 5 cm). See Figure 3.

Figure 3

• Press and release the On/Scan button.• The measurement will be displayed within two seconds.• The thermometer will produce an audible indication when the measurement is complete if audio is enabled. • Wait at least one second before taking the next measurement.• If a continuous series of measurements is being performed, wait at least 30 seconds after every 5th measurement.

Body Measurement Results• If the measurement is below 93.2 °F (34.0 °C), the display will show “Lo”, a green backlight and beep three times if audio is enabled.

09

• If the measurement is between 93.3 °F and 99.2 °F (34.1 °C and 37.3 °C) the display will show the temperature, a green backlight, a happy face icon and beep once if audio is enabled. This indicates normal body temperature.• If the measurement is between 99.3 °F and 100.5 °F (37.4 °C and 38.0 °C), the display will show the temperature, a yellow backlight, a sad face icon and emit a series of beeps if audio is enabled. This indicates a slight fever• If the measurement is between 100.6 °F and 109.2 °F (38.1 °C and 42.9 °C), the display will show the temperature, a red backlight, a sad face icon and emit a series of beeps if audio is enabled. This indicates a high fever.• If the measurement is greater than 109.2 °F (42.9 °C), the display will show “Hi”, a green backlight and beep three times if audio is enabled.

2.6 Surface Temperature

Taking a Surface Measurement• Ensure the distance between the thermometer and the surface to be measured is between 0.4” and 2.0” (1 cm and 5 cm).• Press and release the On/Scan button.• The measurement will be displayed within one second.• The thermometer will produce a tone when the measurement is complete if audio is enabled.

Surface Measurement Results• If the temperature is less than 32.0 °F (0.0 °C), the display will show “Lo”, a green backlight and beep three times if audio is enabled.• If the temperature is between 32.0 °F and 212.0 °F (0.0 °C and 100.0 °C), the display will show the temperature, a green backlight and beep once if audio is enabled.• If the temperature is greater than 212.0 °F (100.0 °C), the display will show “Hi”, a green backlight and beep three times if audio is enabled.

2.7 Memory Mode

The thermometer will automatically store the previous 50 temperature measurements. Temperatures that registered High or Low are out of range and are not stored.• To enter Memory Mode, press the Memo Button while the unit is o� or after the completion of a temperature reading.• Upon entering Memory Mode, the most recent temperature measurement will be displayed.• Press the Memo Button to display the next temperature measurement.• Each stored measurement will display the following information: o The memory index value (1-50, newest to oldest). o The temperature.

10

2.8 Parameter Mode

The thermometer has four parameters that can be tailored to certain populations or environmental conditions.

Entering Parameter Mode• Ensure the thermometer is on.• Press and hold the Set Button until “F1” and then “Unit” is displayed.

Temperature Units (F1)The thermometer can be set to display the temperature in Fahrenheit or Celsius.• Press either the Memo Button or the Mode Button to toggle between Fahrenheit and Celsius.• When the desired units have been selected, press the Set Button to move to the next parameter.

Fever Threshold (F2)The thermometer allows the fever threshold to be modified. This is the value at which the thermometer will indicate a slight fever. The default value is 100.5 °F.• The threshold value will be displayed as it is modified. • Press the Memo Button to increase the threshold by approximately 0.2 °F (0.1 °C).• Press the Mode Button to decrease the threshold by approximately 0.2 °F (0.1 °C).• When the desired threshold has been selected, press the Set Button to move to the next parameter.

Audio (F3)The thermometer can be used with audio enabled or disabled.• Press either the Memo Button or the Mode Button to toggle between audio enabled and audio disabled.• When the desired audio setting has been selected, press the Set Button to move to the final parameter.Note: The audio can also be enabled and disabled via Set Button when not in Parameter Mode.

o The units (°F or °C). o Whether body or surface temperature. o For body temperature, a happy or sad face icon

• Every stored measurement will be displayed with a green backlight.• To clear the stored values, press and hold the Memory Button until “Clr” is displayed.• Empty memory cells will be displayed with “ - - - -“ as the temperature value.

11

Temperature O�set (F4)The thermometer allows a surface temperature o�set to be entered. This will increase or decrease thedisplayed surface temperature, based on the o�set value. The default o�set value is zero. The o�setrange is ± 9.0 °F (± 5.0 °C).• The o�set value is displayed as it is modified.• Press the Memo Button to increase the o�set by approximately 0.2 °F (0.1 °C).• Press the Mode Button to decrease the o�set by approximately 0.2 °F (0.1 °C).• When the desired temperature o�set has been selected, press the Set Button to exit Parameter Mode.

2.9 Notes

• If you experience problems with this thermometer, such as configuration, maintenance or use, please contact the SERVICE PERSONNEL. Do not attempt to open or repair the device yourself. • Please report to us any unexpected operation or events. • The patient is an intended operator. They can determine the state of the batteries and change the batteries. The patient can maintain the device and its accessories according to the user manual under normal circumstances.

12

3 - Troubleshooting

4 – Replacing the Batteries

Caution: The thermometer does not operate with dead or low batteries and does not allow connection to an external power supply.1) Before replacing the batteries, ensure the device is o�.2) Pull the battery cover forward as indicated by the arrow.3) Remove the old batteries.4) Insert two AAA-size batteries. Ensure correct polarity as indicated inside the battery cover.5) Slide the battery cover back in until it snaps in place.6) Dispose of the batteries in accordance with local regulations.

The screen flickers and then turns o�.

Replace the batteries. If the error persists, the device may be damaged.

Replace batteries.

The ambient temperature has changed too quickly.

Allow the thermometer to adjust to the new temperature.

Blank Screena) The power is o�b) Improper battery installationc) The batteries are depleted.d) Device is damaged

a) Press the On/Scan button.b) Check battery polarity.c) Replace the batteriesd) Contact retailer or service center.

Body: The temperature measuredis not within the typical humanbody temperature range of 93.2 °F to 109.2 °F (34.0 °C to 42.9 °C).Surface: The temperature measureis not within the measurable rangeof 32.0 °F – 212.0 °F (0.0 °C – 100.0 °C).

Ensure the correct distance and location is being used to measure the temperature.

Do not attempt to measure temperatures outside the allowable range.

Situation

Improper Distance Ensure the proper distance is used: 0.4” – 2.0” (1 cm – 5 cm).

Incorrect test position. The subject’s hair, antipyreticstickers or perspiration is a�ectingthe measurement.

Remove any items that may interfere with the measurement.

F4 temperature o�set is setincorrectly.

Adjust the temperature o�set value.

The device temperature exceeds the allowable operating temperature range.

Move to a location within theoperating temperature range andallow the thermometer to adjust to the new temperature.

Message Solution

Ensure the correct position is used.

Battery capacity is too low.Temperature measurement isnot allowed.

13

• Only use the recommended batteries. • Do not attempt to recharge non-rechargeable batteries.• Do not dispose of batteries in a fire.• Remove the batteries if the thermometer is not to be used for a long period of time.

5 – Cleaning, Care and Storage• It is important to protect the infrared lens from dirt and damage; it is very delicate.• Use a clean, soft cloth to clean the surface of the device and LCD. Do not use solvents or immerse the device in water or other liquids.• Always keep the thermometer within the storage temperature range of -4.0 °F to 131.0 °F (-20.0 ° to 55.0 °C) and humidity range of ≤ 93% (non-condensing) as specified.• It is recommended to store the thermometer in a dry location free from dust.• Do not expose the thermometer to direct sunlight, high temperature or humidity or any other extreme environmen tal conditions as it may a�ect the proper operation of the device.• If the ambient temperature changes too much, such as moving the thermometer from a cold room to a warm room, allow the thermometer to adjust to the new temperature. This may take up to 30 minutes. Condensation may have formed on the infrared sensor.

6 – Disposal• Batteries should be disposed of in accordance with local regulations.• Do not dispose of the thermometer in the unsorted municipal waste stream. Enquire about options

Warning Do not recharge, disassemble, or dispose of in a fire.

• The typical service life for a set of new batteries is 2000 measurements with an operation time of 18

seconds per measurement.

If the device does not function after replacing the batteries:• Check for proper battery polarity.• Try a fresh set of batteries.• The unit may have locked up if the batteries were removed while the unit was powered. In this case, remove the batteries, wait 30 seconds, and then reinsert the batteries.

for environmentally friendly and appropriate disposal. Take local regulations into account.

7 – CallibrationThe thermometer is initially calibrated at the time of manufacture. If this thermometer is used according tothe instructions, periodic re-adjustment is not required. If at any time you question the accuracy of thetemperature measurements, please contact service personnel.

14

7 – EMC Declaration

• This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be a�ected by portable and mobile RF communications equipment.• Do not use a mobile phone or other devices that emit electromagnetic fields near the unit. This may result in an incorrect operation of the unit.• Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation.• Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environments specified below. The customer or user of the Non-Contact Infrared Body Thermometer should ensure that it is used in such an environment.

Power Frequency(50 Hz/60 Hz)Magnetic FieldIEC 61000-4-8

Electrostatic Discharge (ESD)

IEC 61000-4-2

Electrical FastTransient/BurstIEC 61000-4-4

SurgeIEC 61000-4-5

Voltage dips, short interruptions and voltage

variations on power supply input lines

IEC 61000-4-11

Immunity Test IEC 60601 Test Level

±6 kV contact±8 kV air

±2 kV for power supply lines±1 kV for input/output lines

±1 kV line(s) to line(s)±2 kV for line(s) to earth

<5% UT (>95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 secs

3 A/m

Compliance Level

±6 kV contact±8 kV air

Not Applicable

Not Applicable

Not Applicable

3 A/m

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Non-Contact Thermometer requires continued operation during mains power interruption, it is recommended that the device be powered from an uninterruptable power supply or battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

15

2.8 Parameter Mode

The thermometer has four parameters that can be tailored to certain populations or environmental conditions.

Entering Parameter Mode• Ensure the thermometer is on.• Press and hold the Set Button until “F1” and then “Unit” is displayed.

Temperature Units (F1)The thermometer can be set to display the temperature in Fahrenheit or Celsius.• Press either the Memo Button or the Mode Button to toggle between Fahrenheit and Celsius.• When the desired units have been selected, press the Set Button to move to the next parameter.

Fever Threshold (F2)The thermometer allows the fever threshold to be modified. This is the value at which the thermometer will indicate a slight fever. The default value is 100.5 °F.• The threshold value will be displayed as it is modified. • Press the Memo Button to increase the threshold by approximately 0.2 °F (0.1 °C).• Press the Mode Button to decrease the threshold by approximately 0.2 °F (0.1 °C).• When the desired threshold has been selected, press the Set Button to move to the next parameter.

Audio (F3)The thermometer can be used with audio enabled or disabled.• Press either the Memo Button or the Mode Button to toggle between audio enabled and audio disabled.• When the desired audio setting has been selected, press the Set Button to move to the final parameter.Note: The audio can also be enabled and disabled via Set Button when not in Parameter Mode.

The Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of the Non-Contact Infrared Thermometer should ensure that it is used in such an environment.

The Non-Contact Infrared Body Thermometer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The Non-Contact Infrared Body Thermometer is suitable for use in al establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Group 1

Class B

Not Applicable

Not Applicable

RF Emissions CISPR 11RF EmissionCISPR 11Harmonic EmissionsIEC 6100-3-2Voltage Fluctuations/Flicker EmissionsIEC 61000-3-3

Guidance and Manufacturer’s Declaration – Electromagnetic Emission

Emission Test Compliance Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Non-Contact Infrared Thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended Separation Distanced = 1.2 √p (150 kHz – 80 MHz)d = 1.2 √p (80 MHz – 800 MHz)d = 1.2 √p (800 MHz – 2.5 GHz)Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters.Field strengths from fixed RF transmitters, as determined by electromagnetic site surveysª should be less than the compliance level in each frequencyrange. Interference may occur in the vicinity of equipment marked with the following symbol:

The Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environments specified below. The customer or user of the Non-Contact Infrared Body Thermometer should ensure that it is used in such an environment.

Conducted RFIEC 61000-4-6

3VRMS150kHz to80 MHz

NotApplicable

Radiated RFIRC61000-4-3

3 V/M80MHz to2.5 GHz

3 V/M

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Electromagnetic Environment - GuidanceComplianceLevel

IEC 60601Test Level

Immunity Test

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is a�ected by absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

16

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Non-Contact Infrared Thermometer

The Non-Contact Infrared Thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power of Transmitter (W)

Separation distance according to frequency of transmitter (m)

150 kHz – 80 MHzd = 1.2√p

80 MHz – 800 MHzd = 1.2√p

800 MHz – 2.5 GHzd = 2.3√p

0.01

0.1

1

10

100

0.12

0.38

1.2

3.8

12

0.12

0.38

1.2

3.8

12

0.23

0.73

2.3

7.3

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is a�ected by the absorption and reflection from structures, objects and people.

MANUFACTURED FOR :

MEDSOURCE4201 NOREX DRIVECHASKA, MN 5531 8800-876-8264info@medsourcelabs .com www.medsourcelabs.com

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